Table 2 The Norwegian Regulatory Context*

Size and Scale of the Norwegian Specialized Health System

• 1,967,758 million people were treated in hospital units in 2018.

• 114,028 thousand people employed in the specialist healthcare services in 2018.

• 2667 EUR (27,100 NOK) in operating expenses per inhabitant in 2018.

Governmental Regulatory and Policy-making Bodies

• The Ministry of Health and Care Services directs health and care services through comprehensive legislation, annual budgetary allocations and by means of various governmental institutions such as the Norwegian Board of Health Supervision and the Norwegian Directorate of Health.

Quality and Safety Challenges in the Norwegian Healthcare Services

• Indications of an 11,9% adverse event rate in 2018, against 13,7% in 2017 in the hospital context.

• Lack of adequate management responsibility and competencies.

• Lack of competence and implementation of the Internal Control Regulations in the Healthcare Services developed to ensure sound professional practice and service quality and safety in the Norwegian healthcare system.

• Areas of non-compliance with governmental requirements are believed to be related to hospital managers’ attitudes, values and the development of organizational culture with emphasize on learning.

Governmental Regulatory Response to these Challenges

• Regulators adjusted and replaced the former Internal Control Regulation in the Healthcare Services with the new Regulation for management and quality improvement in the healthcare services (hereafter referred to as: the Quality Improvement Regulation), effective from January 1st 2017.

• This Quality Improvement Regulation embodies the overall aim of contributing to professionally sound practice, quality improvement and patient- and user safety, and compliance with other requirements.

• It requires hospitals to plan and establish barriers in order to discover failure before it has consequences for the patients, and to handle, correct and evaluate adverse events and failures.

• The focus on the managerial level and the role of leaders in risk management and quality improvement increased significantly with the new Quality Improvement Regulation.

• The Ministry of Health and Care Services requests knowledge about how the hospitals comply with- and implement the new Quality Improvement Regulation.